In the evolving biosimilar landscape, patent challenges remain a critical strategy to clear the path for market entry. Recent reforms at the Patent Trial and Appeal Board (PTAB) under Director John Squires have significantly altered the inter partes reviews (IPRs) landscape, leading to a steep decline in institution rates. While this shift may initially appear
Biosimilars continue to make a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a
Introduction
On January 16, 2026, the U.S. Supreme Court agreed to hear Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., a patent dispute that could reshape the landscape of generic drug competition and patent enforcement.
This case centers on a contentious question: If a generic drug is labeled only for non-infringing uses (a so-called
On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), announced a new strategy aimed at dramatically reducing the cost and timeline of biosimilar development (U.S. Food and Drug Administration,FDA Moves to Accelerate
The U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 affirmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed. Cir. July 16, 2025).[1] This appeal concerned the question of when and how a single-patient study can provide sufficient
Introduction
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This initiative formalizes the agency’s long-building effort to incorporate New Approach Methodologies (NAMs) into regulatory review and follows the release of draft guidance
With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close analogs of existing reference blockbuster branded products. This post provides a roadmap into this evolution, focusing on potential biosimilar approvals and launches
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more
On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed a five-year patent term extension (“PTE”) for Merck’s sugammadex patent, holding that the district court had correctly calculated PTE based on the issue date of the original patent rather than the issue date of the reissued patent.[1]
Background
The case
In our previous articles, we reported that the Federal Circuit affirmed the district court’s decision on December 20, 2024 ordering Teva Pharmaceuticals (“Teva”) to delist certain patents related to Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange Book, and that the Federal Circuit subsequently stayed that delisting order on January 22, 2025 following a